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Research Compliance

Institutional Research Board (IRB)

Recommendations to Faculty on Student Research Protocols

Preamble

Student research at Salisbury University has become one of
the distinguishing characteristics of our mission and has
brought us national recognition. The IRB/Committee on Human
Research strongly supports student research so long as it is
conceived and carried out in a way that insures the rights of
human subjects are protected.

The Committee would like to remind faculty and students alike
that any research undertaken by students as part of or related
to University courses or activities is subject to review by the
committee. That is our charge as mandated by federal statute,
the University System of Maryland and our own ethical
responsibilities as committee members.

(Code of Federal Regulations, Part 46, Title 45 and
University System of Maryland Policy on Human Subjects: 105.0
IV-2.10)

In the last several years, the increased number and variety
of undergraduate student protocols involving human subjects and
full committee review have greatly increased and have caused
some problems both for the students and the committee.
Understandably, it takes students time to identify, develop and
propose a protocol and it takes the committee a fair amount of
time to work through these protocols. This has created a
“crunch” often near the end of the semester that has left
students and committee members increasingly frustrated.

With these concerns in mind, and in a spirit of cooperation,
we would like to make the following recommendations (mostly
reminders and suggestions) to faculty members who are working
with students engaged in research with human subjects.

Recommendations

On all undergraduate student protocols that require full
committee review, it is the committee’s policy that the
faculty member must be listed as the primary investigator.
This is to protect the subjects, the student researcher, the
faculty member and the university. It follows that the
faculty member, as primary investigator, must be in
attendance at the committee review meeting.

When students are doing research, they are often
learning how to do research in a particular field of study.
While we recognize that it takes time for students to come
to a topic and develop a protocol, we recommend to faculty
that you encourage them to do so as soon into the semester
as possible so that the committee will have ample time to
receive, discuss, make recommendations and approve. This
also gives the committee time to perform its educational
function; that is, helping students understand the
importance of their ethical responsibilities to human
subjects, particularly in the areas of risk, privacy and
confidentiality.

Because undergraduate students’ work frequently
does not meet the level of verifiable scientific research,
we have to be particularly cautious with protocols that
involve sensitive topics or protected populations. We have
to look very carefully at protocols that include illegal
behaviors (such as drugs and alcohol) or could cause
compromises of privacy (such as sexual and bathroom
behaviors) or involve vulnerable populations (such as
children and prisoners) or forgo prior consent (such as
interacting with unwitting subjects). When students chose
protocols that are classified as either ‘exempt’ or
‘expedited’ by the federal guidelines, turn around time is
much quicker. A number of faculty members have found it
beneficial to require students to select research projects
that do not involve full committee review.

If a student should choose to develop a protocol
which requires full committee review, we ask the faculty
member to remind the student early on about our deadlines
for submission and counsel the student that the process of
approval can be lengthy.

A complaint sometimes voiced about the committee’s
operation is that its members get overly involved in the
details of research methodology; something which is
perceived to be outside of the committee’s mandate.
Actually, we try not to be overly intrusive into research
methodology but such discussions are within our purview
because a faulty methodology can negatively impact the
subjects in a protocol. Again, timely submission of
protocols will help all of us in our mission to educate our
students in the important responsibility they have to their
subjects to do good scientific research.

Conclusion

To facilitate its primary mission to protect human subjects
in research and to educate our students in the essentials of
ethical research, we as a committee stand ready to help faculty
and students in any way possible. We welcome requests to come
into your classes and to talk with you individually about your
research.